Gas Seal Pad

ABSTRACT

A pad is provided having a body for providing a gas seal over a surgical site, a port extending between a first surface of the body and a second surface of the body and sized accept a surgical instrument, and a lumen situated along the body and having a first opening and a second opening, the second opening aligned with the surgical site for communicating a fluid flow to the surgical site.

CROSS-REFERENCE TO RELATED APPLICATION(S)

This application is a continuation patent application of U.S.application Ser. No. 17/668,454, filed Feb. 10, 2022, which is adivisional patent application of U.S. application Ser. No. 16/225,049,filed Dec. 19, 2018, now U.S. Pat. No. 11,278,318, which claims priorityto and the benefit of U.S. Provisional Application No. 62/610,662, filedDec. 27, 2017, the disclosures of each of which are hereby incorporatedby reference in their entireties.

TECHNICAL FIELD

Example embodiments relate generally to surgical devices and moreparticularly to apparatuses for providing a substantially gas tight sealat a site of incision.

BACKGROUND

Conventionally, trocars are inserted into a surgical site of a patientto serve as a portal for subsequent introduction of insufflation gasand/or placement of other instruments into the surgical site. However,conventional trocars are large, awkward, and difficult to accuratelyinsert and place within the patient.

SUMMARY

In some embodiments, an apparatus is provided. The apparatus can includea body for providing a gas seal over a surgical site, a port extendingbetween a first surface of the body and a second surface of the body andsized to accept a surgical instrument, and a lumen situated along thebody and having a first opening and a second opening, the second openingaligned with the surgical site for communicating a fluid flow to thesurgical site. The apparatus can further include one of a flap, septum,a one-way valve, or combinations thereof for sealing the port. The portcan be sized to form a gas seal with the surgical instrument. Theapparatus can further include a tube extending from the second openingof the lumen toward the surgical site to enhance delivery of the fluidflow to the surgical site. The tube can extend through the lumen. Theapparatus can further include a tab extending from the body to provide afinger grip to facilitate removal of the pad. The apparatus can furtherinclude an adhesive disposed over the at least a portion of the secondsurface of the body to aid in forming the gas seal over the surgicalsite.

In some embodiments, a method is provided. The method includes placingpad over a surgical site to form a gas seal between the pad and thesurgical site, the pad having a port in alignment with the surgicalsite, inserting a surgical instrument through the port into the surgicalsite while maintaining a gas-sealed engagement with the surgicalinstrument, and communicating a fluid flow through the pad into thesurgical site. The step of communicating can include introducing thefluid flow from a fluid source to a first opening of a lumen and exitingthe fluid flow from a second opening of the lumen. The fluid flow caninclude an insufflation gas. The step of communicating can includeinsufflating the surgical site with the insufflation gas. The step ofplacing can include adhering, by an adhesive disposed over at least aportion of a surface of the pad over the surgical site. The method canfurther include grasping and pulling a tab extending from the pad toremove the pad from the surgical site. The method can further includeadvancing a tip of the surgical instrument to a target anatomicalstructure.

In some embodiments, a method of endoscopic vessel harvesting isprovided. The method includes placing a pad over an incision at asurgical site to form a gas seal between the pad and the surgical site,the pad having a port in alignment with the incision, inserting anendoscopic vessel harvester through the port into the incision whilemaintaining a gas-sealed engagement with the endoscopic vesselharvester, insufflating the surgical site by introducing gas flow intothe incision, and harvesting a target vessel using the endoscopic vesselharvester.

The step of placing can include adhering, by an adhesive disposed overat least a portion of a surface of the body, the pad over the surgicalsite. The method can further include grasping and pulling a portion ofthe body to remove the pad from the surgical site. The method canfurther include advancing a tip of the surgical instrument to a targetanatomical structure. The method can further include cutting theincision at the surgical site. The method can further include dissectingto a depth of a target vessel. The introducing the insufflation gas flowfrom the fluid source can be through the port in the body into theincision.

In some embodiments an apparatus is provided. The Apparatus can includea body for providing a gas seal over a surgical site, a sealing memberextending through the body, the sealing member having a first openingand a second opening through which a surgical device can be directedinto the surgical site, and a channel along the body having a firstopening at one end of the channel and a second opening at an opposingend of the channel in fluid communication with the sealing member. Theapparatus can further include a stiffener situated within the sealingmember to provide reinforcement to the sealing member. The stiffener caninclude one or more geometric protrusions extending therefrom to providea bonding surface for the body and the stiffener. The first opening andthe second opening can be sized to form a gas seal with the surgicalinstrument inserted therethrough. The apparatus can further include anadhesive disposed over the at least a portion of the second surface ofthe body to aid in forming the gas seal over the surgical site.

BRIEF DESCRIPTION OF THE DRAWINGS

Illustrative, non-limiting example embodiments will be more clearlyunderstood from the following detailed description taken in conjunctionwith the accompanying drawings.

FIGS. 1A, 1B, AND 1C are perspective, side, and bottom views of asealing device in accordance with various embodiments.

FIGS. 2A, 2B, 2C, 2D, 2E, AND 2F are diagrams illustrating steps for amethod of using the sealing device of FIGS. 1A-1C in accordance withvarious embodiments.

FIGS. 3A, 3B, 3C, 3D, 3E, 3F, AND 3G are diagrams illustrating steps foranother method of using the sealing device of FIGS. 1A-1C in accordancewith various embodiments.

FIGS. 4A, 4B, 4C, and 4D are top and side views of a sealing device inaccordance with various embodiments.

FIGS. 5A and 5B are diagrams illustrating steps for another method ofusing the sealing device of FIGS. 4A, 4B, 4C, and 4D in accordance withvarious embodiments.

DETAILED DESCRIPTION OF THE EMBODIMENTS

Various exemplary embodiments will be described more fully hereinafterwith reference to the accompanying drawings, in which some exampleembodiments are shown. The present inventive concept may, however, beembodied in many different forms and should not be construed as limitedto the example embodiments set forth herein. Rather, these exampleembodiments are provided so that this disclosure will be thorough andcomplete, and will fully convey the scope of the present inventiveconcept to those skilled in the art. In the drawings, the sizes andrelative sizes of layers and regions may be exaggerated for clarity.Like numerals refer to like elements throughout.

It will be understood that when an element is referred to as being“connected” or “coupled” to another element, it can be directlyconnected or coupled to the other element or intervening elements may bepresent. In contrast, when an element is referred to as being “directlyconnected” or “directly coupled” to another element, there are nointervening elements present. Other words used to describe therelationship between elements should be interpreted in a like fashion(e.g., “between” versus “directly between,” “adjacent” versus “directlyadjacent,” etc.).

Unless otherwise defined, all terms (including technical and scientificterms) used herein have the same meaning as commonly understood by oneof ordinary skill in the art to which this inventive concept belongs. Itwill be further understood that terms, such as those defined in commonlyused dictionaries, should be interpreted as having a meaning that isconsistent with their meaning in the context of the relevant art andwill not be interpreted in an idealized or overly formal sense unlessexpressly so defined herein.

Embodiments of the present disclosure generally apply to surgicalinstruments. The various embodiments of the present disclosure can beused, for example, to provide a flexible, gas-sealed sealing device forobviating the need for a trocar during an endoscopic procedure.

FIGS. 1A-1C illustrate a sealing device or apparatus 100, such as a padfor placement at a surgical site to create a substantially tight gasseal. For example, the gas seal can be a substantially gas-tight seal.Referring first to FIG. 1A, pad 100, in accordance with variousembodiments of the present disclosure, can include a body 101 having afirst surface 101 a and a second surface 101 b for placement at asurgical site over, for instance, an incision. To facilitate formationof the substantially gas-tight seal, the body 101 can be sufficientlybigger than the surgical site so as to completely cover the incision. Inone embodiment, the body 101 can be circular in shape with a diametersufficiently larger than the incision and large enough to providesufficient surface area to adhere to the target site, while not beingoverly cumbersome for a particular application site. For example, thediameter of the body 101 can be 3-5 inches. The body 101 can also besized and shaped to allow for mobility while maintaining adhesion to atarget site, for example, at a knee or elbow. Although shown in FIG. 1Aas having a substantially circular shape, it will be apparent in view ofthis disclosure that the body 101 can be any shape including, forexample, square, rectangular, hexagonal, triangular, octagonal, oval, across, any geometric design, any other suitable shape, or combinationsthereof, so long as the body is capable of covering the incision to forma gas-tight seal. In some embodiments, the body 101 can have a diameterbetween about 1″ to about 10″ to facilitate covering the incision toform a gas-tight seal. However, it will be apparent in view of thisdisclosure that any size body 101 or device 100 capable of covering theincision to form a gas-tight seal can be used in accordance with variousembodiments.

To the extent it is desirable for the device 100 to conform to thepatient's body topography to aid in forming the gas seal, in someembodiments, the body 101 can be sufficiently flexible for conforming tosurface of the patient at the surgical site. In this regard, as shown inFIGS. 1A-1B, the body 101 can be substantially thin to promoteflexibility of the device 100. In one embodiment, the body can beprovided with a thickness ranging from about 0.01″ to about 1.0″ thick.Of course, the thickness of the body can be provided with a rangeoutside the noted range depending on the application. In addition, thebody 101 can be from a substantially fluid impermeable material toprovide a gas barrier over the surgical site. Examples of such amaterial can include, for example, polyurethane, an elastomer such assilicone, EPDM, Flourocarbon, Neoprene, Nitrile, a polymer such asPolyurethane, Polyethelyne, Polyproplyne, Polystyrene, PET, PTFE, PFA,FEP, EVA, bioresorables (PLA, PGA, PCL), any other suitable material, orcombinations thereof. In one embodiment, wherein the device is to beplaced against the skin or other tissue, the material from which thedevice can be made may be biocompatible. In some embodiments, thematerial of the body 101 can also advantageously be tear resistant toprevent inadvertent destruction or leakage. For example, in someembodiments, the body 101 can have a durometer hardness of about Shore10A to about Shore 90A.

Referring again to FIG. 1A, the body 101 can also include a port 103extending from one of the first surface 101 a to the second surface 101b to function as a portal for introducing one or more surgicalinstruments into the patient at the surgical site on incision location.In some embodiments, the port 103 can be sized to be slightly smallerthan a diameter of the surgical instrument being inserted. To that end,the port 103 can provide a substantially tight, elastically gas-sealedfit with the surgical instrument. In some embodiments, the port 103 canbe substantially centrally located within the body 101. However, it willbe apparent in view of this disclosure that the port 103, in accordancewith various embodiments, can be located anywhere within the body 101.In some embodiments the port 103 can be provided with a resealableelement (not shown) such as, for example, a resealable flap, aresealable septum, a one-way valve, or combinations thereof to providegas-sealing of the port 103 when no surgical instrument is presenttherein while permitting insertion of one or more surgical instruments.In some embodiments, the resealable element can prohibit ambient airflowinto the patient via the port 103 and prevent escape of insufflation gasthrough the port 103. Thus, the gas seal created by the body 101 ismaintained regardless of the presence of a surgical instrument in theport 103.

Still referring to FIG. 1A, the body 101 can also include, in oneembodiment, a tunnel or lumen 105 for delivering a fluid flow throughthe device 100 and into the surgical site. The lumen 105, asillustrated, includes a first opening 105 a at one end for receiving afluid flow from a fluid source. The lumen 105, as illustrated, alsoincludes a second opening 105 b at an opposite end aligned with thesurgical site for delivering the fluid flow thereto. For example, thelumen 105 can extend radially inward from an edge 101 c of the body 101toward the port 103. In some embodiments, the lumen 105 can extend fromthe first opening 105 a positioned anywhere on the first surface 101 aor the edge 101 c of the body 101 to the second opening 105 b positionedanywhere on the second surface 101 b of the body 101 suitable fordelivering the fluid flow to the surgical site. In accordance withvarious embodiments, the first opening 105 a can be connected to acoupling fitting 109 for permitting the fluid source (e.g., a gasinsufflation supply, a saline supply, a water supply, a syringe, or anyother such device or equipment) to be connected to the lumen 105 forcommunicating a gas or other fluid into or out of the patient via thelumen 105. In some embodiments, the fluid source can be provided throughthe port 103 and/or the lumen 105. The coupling fitting 109 can includeany combination of coupling mechanisms for attaching another device tothe device 100, for example, the coupling fitting 109 can be a Luerfitting. The coupling fitting 109 can be made from any combination ofmaterials, for example, metal, plastic, etc. and can be fixedly orremovably attached to the body 101.

In some embodiments, the body 101 can be configured for distalinsufflation such that the fluid source can be provided through a lumenin a medical instrument separate from the device 100. For example, themedical instrument can provide the fluid source through the port 103 orthrough a separate point of entry.

To facilitate removal of the device 100, in one embodiment, the body canbe provided with a tab 106 extending radially outward from the edge 101c of the body 101. In some embodiments, the tab 106 can form a fingergrip for aiding a user in removing the device 100 from the patient. Asshown in FIG. 1A, in one embodiment, tab 106 can be provided as anextension of lumen 105. However, it will be apparent in view of thisdisclosure that, in accordance with various embodiments, the device 100may be designed without a tab 106 or with a tab 106 that is separatefrom the lumen 105.

To the extent desired, a fluid conduit such as tube 107 can be providedextending through the lumen 105. In an embodiment, as illustrated inFIG. 1B, the tube 107, can extend through the lumen 105 between a firstend 107 a and a second end 107 b. To maintain the gas seal between thedevice 100 and the surgical site, in some embodiments, the tube 107 canform a gas seal (e.g., by welding, adhesive, or elastomeric interferencefit) with the lumen 105. As shown in FIG. 1B, in some embodiments, thesecond end 107 b of the tube 107 can extend beyond the second opening105 b of the lumen 105. However, in some embodiments, the second end 107b can, for example, be flush with the second opening 105 b or terminatedwithin the lumen 105 so as to position the second end 107 b over orabove the surgical site. In an alternative embodiment, the first end 107a of the tube 107 can be coupled to the second opening 105 b of thelumen 105 and extend therefrom. In such an embodiment, the first end 107a of the tube 107 can form a gas seal (e.g., by welding, adhesive, orelastomeric interference fit) with the second opening 105 b of the lumen105. More generally, any relative configuration of the tube 107 and thelumen 105 capable of delivering a fluid to the surgical site can be usedin accordance with various embodiments. The tube 107 can be sized andshaped to all passage through intermediary layers (e.g., skin, fat,etc.) to a target location (e.g., vessel). For example, the tube 107 canbe ½ inches long to 2 inches long, however, these dimensions can varybased on the particular application and the target location.

As shown in FIG. 1B, to provide enhanced delivery of the fluid into thesurgical site, the second end 107 b can extend out of the second opening105 b of the lumen 105 for a predetermined distance into the patient.Because different surgical procedures, different patients, and differentanatomical structures can require incisions of varying depth, n someembodiments, the tube 107 can be trimmable so as to permit customizationof the predetermined distance the tube 107 extends into the patient.

For maintaining the gas seal provided by the body 101 over the surgicalincision, the tube 107, in one embodiment, can be sufficiently flexibleto permit bending of the tube 107 with the body 101. In one embodiment,the tube 107 can further be sufficiently rigid to permit advancement ofthe tube 107 into the patient and to prevent crushing and/or occlusionof the tube 107. To that end, in some embodiments, the tube 107 can beconstructed of, for example, PVC, Tygon, Silicone, PET, Polyurethane,any other suitable material, or combinations thereof.

In accordance with various embodiments, the first end 107 a of the tubecan be coupled to the coupling fitting 109 for permitting the fluidsource (e.g., a gas insufflation supply, a saline supply, a watersupply, a syringe, or any other such device or equipment) to beconnected to the tube 107 for communicating a gas or other fluid into orout of the patient via the tube 107.

However, it will be apparent in view of this disclosure that, in someembodiments, the device 100 may not include a tube 107. In suchembodiments the lumen 105 itself can provide passage for the gas orother fluid into or out of the patient. Additionally, in suchembodiments, the coupling fitting 109 can be directly attached to thedevice 100 at the first opening 105 a. In some embodiments, the secondend 107 b and the port 103 can be the same opening.

Referring now to FIG. 1C, to form a gas seal and to maintain a positionof the device 100 following placement on the patient, an adhesive 111can be disposed on at least a portion of the second surface 101 b of thebody 101 and protected by a removable liner. In some embodiments, theadhesive 111 can be selected to permit multiple adhere-remove cycles forrepositioning of the body 101 on the patient. For example, the adhesive111, in some embodiments, can include any suitable medical adhesive suchas, for example, a silicone gel adhesive, Acrylic adhesive, orpolyurethane adhesive. Although described herein as having an adhesive111, it will be apparent in view of this disclosure that any material orsurface treatment suitable for promoting gas-sealed engagement betweenthe patient and the device 100 can be used in accordance with variousembodiments. As would be appreciated by one skilled in the art, anadhesive can be applied separately from the body 101 and adhere the body101 to the patient without departing from the scope of the presentinvention.

In some embodiments, the adhesive 111 can be selectively omitted fromportions of the second surface 101 b. Still referring to FIG. 1C, insome embodiments, an adhesive-free zone 113 is provided surrounding theport 103 and the second opening 105 b. By omitting the adhesive 111 inthe adhesive-free zone 113, the body 101 is permitted to be locallylaterally displaced. Thus, any surgical instrument inserted through theport 103 can be laterally displaced as needed to position and manipulatethe instrument during a procedure. Furthermore, because theadhesive-free zone 113 permits the pad material surrounding the port 103to stretch relative to the patient's skin, the gas-sealed fit betweenthe body 101 and the surgical instrument can be maintained. By contrast,absent the adhesive-free zone 113, the adhesive 111 would be locallyretained on the skin and thus movement of the surgical instrument wouldcreate separation between the instrument and the body 101, therebycausing a gas leak. The adhesive 111 can also omitted from the tab 106for aiding a user in removing the device 100 after use. By omitting theadhesive 111 on the tab 106, the finger grip formed by the tab 106 doesnot adhere to the patient during use or the user during removal and canthus be readily grasped by the user for removing the device 100.

Referring now to FIGS. 2A-2F, a method for using the device 100 isprovided. As shown in FIG. 2A, the user can place an incision I in theskin S. In some embodiments, such as, for example, a cut-down procedure,the user can continue to dissect to a targeted surgical site. Forexample, in connection with an endoscopic vessel harvesting procedure,the user can dissect until a targeted vessel is found. Referring now toFIG. 2B, the adhesive 111 of the body 101 can be placed onto the skin Ssuch that the port 103 of the device 100 is positioned over the incisionsite, thereby forming a gas seal between the device 100 and the patient.The second end 107 b of the tube can also be fed into the incision siteto a desired depth. Although FIGS. 2A and 2B show formation of theincision I prior to placement of the device 100 on the skin S, it willbe apparent in view of this disclosure that, in some embodiments, thedevice 100 can be placed prior to forming the incision I. For example,where the device 100 includes the lumen without the tube 107, the device100 can be placed and the incision I can be formed through the port 103.

Once the gas seal is formed between the device 100 and the incisionsite, as shown in FIG. 2C, the insufflation supply IS can be connectedto the lumen 105 or the tube 107 (e.g., via coupling fitting 109 asshown) to communicate insufflation gas into the surgical site. As shownin FIG. 2D, a tip 201 and shaft 203 of a surgical instrument 200 (e.g.,an EVH as shown) can be inserted through the port 103 to form agas-sealed fit with the body 101. The surgical instrument 200, as shownin FIG. 2E, can then be advanced to the surgical site and used toperform a surgical procedure such as harvesting a vessel in connectionwith an EVH procedure. As shown in FIG. 2F, the surgical instrument 200can be withdrawn from the port 103 and the device 100 can be removedfrom the patient's skin S (e.g., by grasping and pulling on tab 106).Although described in a particular order herein, it will be apparent inview of this disclosure that the steps of placing an incision I, cuttingdown, placing the device 100, insufflating the surgical site, insertingthe surgical instrument 200, and withdrawing the surgical instrument 200can be performed in any order as appropriate for a particular medicalprocedure.

Referring now to FIGS. 3A-3F, an alternative method for using the device100 is provided. As shown in FIG. 3A, the user can place an initialincision I in the skin S. Referring now to FIG. 3B, in some embodiments,such as, for example, a tip-search technique procedure, the user caninsert a tip 301 of a surgical instrument 300 (e.g., an EVH as shown)through the port 103 of the device 100 to form a gas seal between thedevice 100 and the surgical instrument 300. As shown in FIG. 3C, theuser can advance the tip 301 and at least a portion of a shaft 303 ofthe surgical instrument 300 into the patient via the incision until thedesired surgical site is reached (e.g., a targeted vessel forharvesting). As shown in FIG. 3D, the adhesive 111 of the body 101 canthen be placed onto the skin S to form a gas seal between the patientand the device 100, wherein the port 103 is positioned over the incisionI. The second end 107 b of the tube can also be fed into the incisionsite to a desired depth.

At FIG. 3E, once the gas seal is formed between the device 100 and theincision site, the insufflation supply can be connected to the lumen 105or the tube 107 (e.g., via coupling fitting 109 as shown) to communicateinsufflation gas into the surgical site. As shown in FIG. 3F, thesurgical instrument 300 can be used to perform a surgical procedure suchas harvesting a vessel in an EVH procedure. As shown in FIG. 3G, aftercompletion of the procedure, the surgical instrument 300 can bewithdrawn from the port 103 and the device 100 can be removed from thepatient's skin S (e.g., by grasping and pulling on tab 106). Althoughdescribed in a particular order herein, it will be apparent in view ofthis disclosure that the steps of placing an incision I, inserting thetip 301 through the port 103, advancing the tip 301 into the patientuntil reaching the surgical site, placing the device 100, insufflatingthe surgical site, and withdrawing the surgical instrument 300 can beperformed in any order as appropriate for a particular medicalprocedure.

FIGS. 4A-4D illustrate a device 400 for placement at a surgical site tocreate a substantially tight gas seal. For example, the gas seal can bea substantially gas-tight seal. Referring to FIG. 4A, device 400, inaccordance with various embodiments of the present disclosure, caninclude a body 401, a port 403, and a coupling fitting 409 (e.g., aLuer). The body 401, and coupling fitting 409 can be similar to the body101, tube 107, and coupling fitting 109 discussed with respect to FIGS.1A-3G. In some embodiments, the device 400 can include a sealing member402 and a gas tube 408. The sealing member 402 can be designed to beplaced centrally within the body 401 with an opening sized anddimensioned to allow access to the opening of the port 403 through thesealing member 402. The gas tube 408 can be designed to extend from thesealing member 402 in a lateral direction substantially parallel to thebody 401. FIG. 4A depicts an above-view of the device 400 including thebody 401, the sealing member 402, and the gas tube 408 in relation toone another. As shown in FIG. 4C, the gas tube 408 can include a channel408 a extending along the body 401 having a first opening at one end ofthe channel 408 a (connected to the coupling fitting 409) and a secondopening at an opposing end of the channel 408 a in fluid communicationwith the sealing member (e.g., chamber 410 b of the sealing member 402)through an opening in the sidewall of the sealing member.

Continuing with FIG. 4A, in some embodiments, the body 401 can be anadhesive pad. The adhesive pad can be constructed from any combinationof materials that are sufficiently flexible to conform to the part ofthe body at which the device 400 is being placed. For example, theadhesive pad can be constructed from a polyurethane material. Similarly,the adhesive material of the adhesive pad can be any combination ofadhesive material(s) that allows the body 401 to be removably adhered tothe body. For example, the adhesive can be a silicone adhesive, anacrylic adhesive, or any adhesive known in the art including those thatare biocompatible. In some embodiments, the adhesive material can be amaterial that allows the removal and replacement of the device 400 onthe patient while still maintaining a sufficient seal, as discussedherein. In particular, the adhesive pad seals the device 400 against theskin of a patient, to avoid leaks coming out of an incision.

To facilitate removal of the device 400, in one embodiment, at least aportion of the body 401 can be provided without adhesive to provide aremoval area 410. In some embodiments, the removal area 410 can providean area for a finger to grip for aiding a user in removing the device400 from the patient.

Referring to FIG. 4B, a side view of the device 400 with the sealingmember 402 attached thereto is provided. The sealing member 402 can bepart of the body 401 or can be inserted through the opening in the body401. As depicted in FIG. 4B, the sealing member 402 can be asubstantially cylindrical shape with portions of the sealing member 402positioned above and below the body 401 of the device 400. As would beappreciated by one skilled in the art, the sealing member 402 can be anycombination of shapes, for example, it can be a tubular shape,cylindrical shape, funnel shape, polygonal shape, etc., withoutdeparting from the scope of the present invention. The sealing member402 can be designed to create a seal between the body 401 (adhesive pad)and a surgical instrument 500. In some embodiments, a portion of thesealing member located on the underside of the body 401 can include atapered shape. The tapered shape can be used for insertion of thatportion of the sealing member into an insertion site. In someembodiments, the sealing member 402 can be designed to stretch around ashaft 503 of a surgical instrument 500 to allow insertion of a surgicalinstrument 500 through the port 403 while maintaining a gas-tight sealwhen the device 400 is located on a patient. The sealing member 403 canbe constructed from any combination of flexible medical grade materials.For example, the sealing member 403 can be made from medical gradesilicone. In some embodiments, the sealing member 403 can be coated toallow for easier insertion of the instrument 500 shaft 503. The coatingcan include any combination of lubrications including, for example,paralyne or Teflon and can be applied using any combination of methods,for example, spraying, dipping, vapor, deposition, etc.

Continuing with FIG. 4B, in some embodiments, the sealing member 402 canbe coupled to a gas tube 408. The gas tube 408 can extend from thesealing member 402 in a lateral direction substantially parallel to thebody 401. The gas tube 408 can be integrated with the sealing member402, for example, through injection molding or other manufacturingmethods. Alternatively, the gas tube 408 can be a separate pieceremovably attached to the sealing member 402. In some embodiments, thegas tube 408 can be a substantially cylindrical shape. As would beappreciated by one skilled in the art, the gas tube 408 can be anycombination of shapes, for example, it can be a funnel, shape, polygonalshape, etc., without departing from the scope of the present invention.

In some embodiments, the gas tube 408 can be designed to include orotherwise be coupled to the coupling fitting 409. The coupling fitting409 can be coupled to a first end of the gas tube 408, located oppositeto the end of the gas tube 408 coupled to the sealing member 402, forcoupling the device 400 to another device (e.g., an insufflation tube).The coupling fitting 409 can include any combination of mechanisms tocouple the gas tube 408 to a surgical device or other device. Forexample, the coupling fitting 409 can be a Luer, a threaded head, afriction fit head, etc., or a combination thereof. In some embodiments,the fluid source can be provided through the port 403, through a lumenincorporated with the device 400, and/or through an separate instrumentat a separate point of entry. In some embodiments, the body 401 can beconfigured for distal insufflation such that the fluid source can beprovided through a lumen in a medical instrument separate from thedevice 400.

Referring to FIG. 4C, in some embodiments, the sealing member 402 caninclude one or more chambers 410. FIG. 4C depicts a cross-sectional viewof the device 400 including the sealing member 402. As shown in FIG. 4C,the sealing member 402 can include a chamber 410 a above the port 403and a chamber 410 b below the port 403 with a wall (including an openingfor port 403) diving the two chamber 410 a, 410 b. In some embodiments,the gas tube 408 can be configured to extend through the sealing member402 sidewall into the lower chamber 410 b to create a pathway extendingfrom the connector 409 through the gas tube 408 to the lower chamber 410b of the sealing member 402, as shown in FIG. 4C.

In some embodiments, the sealing member 402 can include one or morechannels 406. FIG. 4C depicts a cross-sectional side view of the device400 with the sealing member 402 attached thereto. The channels 406 canbe located within a portion of the sealing member 402, for example, theportion of the sealing member 402 that is located underneath the body401, as shown in FIG. 4C. Alternatively, the channels 406 can run thefull length of the sealing member 402. The channels 406 can be designedto bump up against a shaft 503 of a medical instrument 500 to create apassageway for gas to pass by (via the channel 408 a) and avoid apinch-off situation where the gas can be cut off when the shaft 503 isinserted in the port 403.

Continuing with FIG. 4C, in some embodiments, the device 400 can includea stiffener 404. The stiffener can be configured to maintain a seal forthe device 400 when a medical instrument has been inserted into the port403. In some embodiments, the stiffener 404 can be designed with asubstantially cylindrical shape. In some embodiments, duringmanufacture, the cylindrical portion of the stiffener 404 can be encasedwithin the sealing member 402 to provide reinforce the seal provided bythe body 402 so that it does not stretch so much that it distorts andleaks. For example, the stiffener 404 can be a separately molded piecethat can be insert molded into the sealing member for encasement, asshown in FIG. 4C. As would be appreciated by one skilled in the art, thestiffener 404 can be any size and shape that is designed to be embeddedwithin, inserted inside, or encased around the sealing member 402 toprovide reinforcement to the sealing member 402. To provide thereinforcement, the stiffener 404 can be made from a stiff material, forexample, polycarbonate or other plastic or metal material.

In some embodiments, the stiffener 404 can include one or more ofgeometric protrusions 404 a, for example, fingers, pedal shapes, etc.that extend therefrom to provide support for the sealing member 402, asdepicted in FIG. 4D. The geometric protrusions 404 a can be designed toextend out from the sealing member 402 underneath and substantiallyparallel to the body 401, as shown in FIG. 4C. In some embodiments, thegeometric protrusions 404 a can be flexible enough to bend and flex toconform to the surface of a patient and can be used to create a bondingsurface to the adhesive pad of the body 401 to the stiffener 404 and/orthe sealing member 402. In some embodiments, the geometric protrusions404 a can be positions on the underside of the body 401, such that itcan be sandwiched between the adhesive pad and the target skin. In someembodiments, the adhesive pad can have a removable liner (not depicted)with a special cut out to allow the geometric protrusions 404 a of thestiffener 404 to stick to the body 401 during manufacturing. The rest ofthe liner can stay on the adhesive pad until removed for placement on apatient.

Referring to FIG. 4D, in some embodiments, the stiffener 404 can have across hole 404 b designed to be coupled to the gas tube 408 to allow gasto pass from the gas tube 408 (e.g. via coupling fitting 409) to theport 403 in the body 401 (e.g., where the gas tube 408 extends throughthe sidewall of the sealing member 402).

In operation, a surgical instrument 500 can be inserted through the port403 of the device 400, and the opening in the body 401, to form agas-sealed fit with the body 401 and advanced to a surgical site toperform a surgical procedure, such as harvesting a vessel. The surgicalinstrument 500 can be a surgical device as discussed with respect to thesurgical devices 200, 300 and can include a tip 501 and a shaft 503. Insome embodiments, the tip 501 and the shaft 503 are sized anddimensioned to fit within the sealing member 402 of the device 400.

Referring to FIG. 5A, in some embodiments, the device 400 can be usedwith a surgical instrument 500 to perform a cut-down procedure, asdiscussed in greater detail with respect to FIGS. 2A-2F. During acut-down procedure using device 400, a user can make an incision andfind a vein, doing some light proximal dissection to open the space alittle under direct visualization. When a vein is found, the user canpeal the liner from the adhesive pad off the underside of the body 401and insert at least a portion of the sealing member 402 into theinsertion site of the patient, as shown in FIG. 5A. With at least aportion of the sealing member 402 inserted, the adhesive pad of the body401 can be placed onto and adhered to a surface of the skin at theincision site to create a gas-tight skin seal at the insertion site.Thereafter, the user can hook up a gas source to the connector 409 andgas can be provided to the insertion site through the gas tube 408 andport 403. When the procedure is done, the user can peal the adhesive padoff the patient and discard or clean the device 400 for reuse.

Referring to FIG. 5B, in some embodiments, the device 400 can be usedwith a surgical instrument 500 to perform a tip-search procedure, asdiscussed in greater detail with respect to FIGS. 3A-3F. During thetip-search procedure using device 400, a user can make a small incisionnear a vein, then using the surgical instrument 500, look through acamera (e.g., within tip 501) to find the vein. Under a tip-search, thevein can be found, not under direct visualization, but through a normalcamera. As depicted in FIG. 5B, the device 400 can be combined with thesurgical instrument 500 prior to beginning the tip-search. Once the userlocates the target vein, the user can peal the liner off the adhesivepad and slide the device 400 down the shaft 503 of the surgicalinstrument 500 until the adhesive pad makes contact with the skin,adhering to the skin and creating the seal. Thereafter, the user canhook up a gas source to the connector 409 and gas can be provided to theinsertion site through the gas type 408 and port 403. When the procedureis done, the user can peal the adhesive pad off the patient and discardor clean the device 400 for reuse.

In operation, the device(s) of the present invention provide systems andmethods for providing a gas-tight seal at a surgical site whileproviding access to the surgical site through a port, as discussed withrespect to FIGS. 1A-5B. Initially, to form the gas-tight seal, the bodyof the device can be placed over a surgical site so that the port issubstantially in alignment with an incision point at the surgical sit.The flexibility of the pad, when placed on the surface of the surgicalsite, allows the pad to contour about the site to create a substantiallygas-tight seal. To enhance adherence of the pad to the surgical site, anadhesive layer of the pad can be placed in contact with a surface of thesurgical site.

With the pad secured to the surgical site, the port of the device can beutilized to insert an appropriate surgical instrument(s). The port canbe sized and dimensioned to receive the surgical instrument whilemaintaining the gas-tight seal at the surgical site. In particular, thesurgical instrument can be inserted through and engage with the portduring entry. With the surgical instrument placed through the porttoward the surgical site, a number of tasks can be performed. The tasksinclude, but are not limited to, accessing a target anatomical structurewithin the surgical site (e.g., via tip of the instrument),communicating a fluid flow into the surgical site, harvesting/removingmaterial from the surgical site, incising at the surgical site, or acombination thereof. The introduction of the fluid flow (e.g.,insufflation gas) can be performed distally from the pad, through theport of the pad via the surgical instrument itself, and/or through alumen/tube of the pad.

Once the surgical procedure has been completed, the pad can be removedfrom the surgical site with minimal impact on the surface of thesurgical site. For example, the pad can be removed by grasping andpulling a tab extending from the pad or a portion of the pad that isvoid of adhesive. The pad, or portions thereof, can then be discarded orcleaned for reuse.

While the present disclosure has been described with reference tocertain embodiments thereof, it should be understood by those skilled inthe art that various changes may be made and equivalents may besubstituted without departing from the true spirit and scope of thedisclosure. In addition, many modifications may be made to adapt to aparticular situation, indication, material and composition of matter,process step or steps, without departing from the spirit and scope ofthe present disclosure. All such modifications are intended to be withinthe scope of the claims appended hereto.

What is claimed is:
 1. A method comprising: identifying a surgical sitehaving an incision; placing a flexible body against the surgical sitesuch that the flexible body engages the surgical site across its entirebottom surface to form a gas seal between the bottom surface of theflexible body and the surgical site; and inserting a surgical instrumentthrough a port, disposed through the flexible body, into the incision atthe surgical site while maintaining a gas-sealed engagement with thesurgical instrument.
 2. The method of claim 1, wherein the step ofplacing further comprises, adhering the flexible body to the surgicalsite with an adhesive disposed on the bottom surface of the flexiblebody.
 3. The method of claim 2, wherein the step of adhering includesdisposing the adhesive over the entire bottom surface of the flexiblebody.
 4. The method of claim 1, wherein, in the step of placing, theflexible body includes one of a flap, septum, a one-way valve, orcombinations thereof for sealing the port when no surgical instrument ispresent therein.
 5. The method of claim 1 further comprising: deformingthe port elastically to form a gas sealed fit with the surgicalinstrument.
 6. The method of claim 1 further comprising: grasping a tabextending from the flexible body; and pulling the tab to remove theflexible body from the surgical site.
 7. The method of claim 1 furthercomprising: delivering a fluid flow through the flexible body into thesurgical site.
 8. The method of claim 1 further comprising: suctioning afluid flow from the surgical site through the flexible body.
 9. Themethod of claim 1 further comprising: cutting the incision at thesurgical site.
 10. A method comprising: engaging a flexible body againsta surgical site so that its entire bottom surface forms a gas seal withthe surgical site; inserting a surgical instrument through a port,disposed through the flexible body, into an incision at the surgicalsite while maintaining a gas-sealed engagement with the surgicalinstrument; and performing a surgical procedure using the surgicalinstrument.
 11. The method of claim 10, wherein the step of engagingfurther comprises, adhering the flexible body to the surgical site withan adhesive disposed on the bottom surface of the flexible body.
 12. Themethod of claim 11, wherein the step of adhering includes disposing theadhesive over the entire bottom surface of the flexible body.
 13. Themethod of claim 10, wherein, in the step of engaging, the flexible bodyincludes one of a flap, septum, a one-way valve, or combinations thereoffor sealing the port when no surgical instrument is present therein. 14.The method of claim 10 further comprising: deforming the portelastically to form a gas-sealed fit with the surgical instrument. 15.The method of claim 10 further comprising: advancing a tip of thesurgical instrument to a target tissue.
 16. The method of claim 15further comprising: dissecting tissue surrounding the target tissue awayfrom the target tissue.
 17. The method of claim 10 further comprising:grasping a tab extending from the flexible body; and pulling the tab toremove the flexible body from the surgical site.
 18. The method of claimof 10 further comprising: aligning the port with the incision on thesurgical site.
 19. The method of claim 10 further comprising: removingthe surgical instrument through the port while maintaining a gas-sealedenvironment.
 20. The method of claim 10, wherein, in the step ofinserting, the surgical instrument is a tissue harvester.